Primary Outcome Measures:
- time until relapse, i.e. any alcohol consumption [ Time Frame: Baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Admission to residential treatment or jail [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
- Depressive symptoms as measured by the Beck Depression Inventory II [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: Yes ]
- Anxiety symptoms as measured by the Beck Anxiety Inventory [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
- Penn Alcohol Craving Scale scores [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
- Obsessive Compulsive Drinking Scale scores [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: Yes ]
- Proportion of days on which alcohol was consumed [ Time Frame: baseline and weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
Purpose: The study is a 13 week open-label study of the use of acamprosate in subjects who have elected to participate in the DUI Court program in Tulsa County. Admission to the DUI Court is completely voluntary. Participants must apply for admission, undergo an initial evaluation, and receive approval by the District Attorney's office and the presiding judge. The four-phase program requires a minimum of 1 year to complete. Each phase requires counseling, mandatory random urine drug screens, mandatory daily breathalyzer tests, a nightly curfew and that the participant be gainfully employed or in school. Currently, approximately 10% of the participants are able to complete the program in the minimum 12 month requirement. The main objective of the study is to evaluate the duration of alcohol abstinence in DUI Court participants receiving acamprosate.
Design: Thirty subjects will be enrolled in the study. New DUI court participants, within 3 months of enrollment, will be invited to participate in the trial. Qualified subjects will receive, in addition to the required DUI court assessments and treatments, a physical examination, baseline safety laboratory, study drug, psychiatric evaluation, depressive and anxiety rating scales, a personality disorder questionnaire and vital signs taken at each visit. Alcohol and substance use will be assessed by self-report and validated with review of the court-ordered laboratory and breathalyzer tests.